[Correction added after online publication 14 July 2010: In the Discussion section ‘solid phenolic core (SPC)’ was replaced with ‘Summary of Product Characteristics (SPC)’].
A multi-centre study of efficacy and safety of Intratect®, a novel intravenous immunoglobulin preparation
Article first published online: 9 JUN 2010
© 2010 British Society for Immunology
Clinical & Experimental Immunology
Volume 161, Issue 3, pages 512–517, September 2010
How to Cite
Kreuz, W., Erdös, M., Rossi, P., Bernatowska, E., Espanol, T. and Maródi, L. (2010), A multi-centre study of efficacy and safety of Intratect®, a novel intravenous immunoglobulin preparation. Clinical & Experimental Immunology, 161: 512–517. doi: 10.1111/j.1365-2249.2010.04187.x
- Issue published online: 16 AUG 2010
- Article first published online: 9 JUN 2010
- Accepted for publication 6 April 2010
- intravenous immunoglobulin;
- primary immunodeficiency
We studied the efficacy, safety and pharmacokinetic profiles of Intratect®, a recently developed polyvalent intravenous immunoglobulin (IVIG) preparation. Fifty-one patients (aged 6–48 years) with primary immunodeficiencies (PID) and established replacement therapy using a licensed IVIG were enrolled and treated for 12 months with Intratect®. Retrospective patient data served as prestudy controls. The primary efficacy variable was the annual rate of acute serious bacterial infection (ASBI) per patient. Secondary parameters were annual rate of acute relevant infection (ARI), days with antibiotic use, fever, absence from school/work and hospitalization. The average IVIG dose was 0·49 g/kg, with an average infusion rate of 2·4 ml/kg/h. The annual ASBI rate/patient was 0·02 and ARIs were detected 128 times during the 630 adverse events in 40 patients, specified mainly as bronchitis, sinusitis, respiratory tract infection, rhinitis and pharyngitis. The annual rate of respiratory ARIs/patient was 2·0 and the rates/patient for days with fever >38°C, school/work absence and hospitalization were 1·81, 3·99 and 0·36, respectively. A total of 630 adverse events (AEs) were observed in 50 of 51 (98·0%) of patients. In 46 of 51 patients the AEs were not related to infusion. Pharmacokinetic studies after the first infusion revealed a mean elimination half-life of 50·8 ± 30·3 days. During this study, 19 of 649 (2·9%) IgG trough levels were below 6 g/l, better than that of reference IVIGs during the 6 months before study start (10 of 201). These data suggest that Intratect® is a well tolerated, safe and effective IgG concentrate for the treatment of patients with PID.